Aerosol delivery of pirfenidone

Abstract

The invention relates to the field of inhalation methods and inhalation devices for liquids. In particular, the invention relates to an inhalation method using an inhalation device having a nebulizing nozzle, and to a method for the generation of an aerosol of an aqueous formulation comprising pirfenidone by means of such inhalation device.

1 . An inhalation device for the generation of an aerosol, the device comprising at least one reservoir containing a liquid composition comprising pirfenidone, wherein the inhalation device is a pump-actuated inhaler adapted to release upon actuation a metered dose of the liquid composition from the reservoir through a nozzle having at least four ejection channels adapted to eject the composition along respective ejection trajectories, and wherein at least two different collision points are provided, and wherein at each of the two collision points two of said ejection trajectories intersect with one another. 
     
     
         2 . The inhalation device of  claim 1 , wherein the metered dose of the liquid composition released upon actuation has a volume of at least 20 μl. 
     
     
         3 . The inhalation device of  claim 1 , wherein a single dose of the liquid composition comprising pirfenidone is released by a plurality of actuations of the inhalation device. 
     
     
         4 . (canceled) 
     
     
         5 . The inhalation device of  claim 1 , wherein the inhalation device comprises a housing, inside this housing at least one reservoir for storing the liquid composition, at least one pumping unit with at least one pumping chamber for generation of a pressure inside said pumping chamber, wherein the pumping chamber is fluidically connected with the reservoir via a check valve which blocks in direction of the reservoir, at least one riser pipe which can be received with at least one reservoir-facing, interior end in said pumping chamber, and a nozzle which is connected liquid-tight to an exterior end of the riser pipe, wherein the interior volume of the at least one pumping chamber is changeable by means of relative motion of the pumping chamber to the riser pipe, and wherein the at least one riser pipe is immobile and firmly attached to the housing or to a nozzle, and the at least one pumping chamber is moveable relative to the housing or to the nozzle. 
     
     
         6 . The inhalation device of  claim 1 , wherein:
 all ejection angles at which the individual trajectories leave the nozzle are identical, or at least one of said ejection angles differs from the other ejection angles; and/or   at least two, or all collision points are located within the same plane perpendicular to the main axis of the nozzle, or on different planes; and/or   with respect to the nozzle's main axis, all collision points are located on the main axis, or at least one collision point is offset from the main axis; and/or   all of the nozzle's ejection channels have the same cross section.   
     
     
         7 . The inhalation device of  claim 1 , wherein
 at least two ejection channels of the nozzle share a common inlet and have intersecting trajectories such as to form a pair or group of ejection channels, or all ejection channels of the nozzle have distinct inlets.   
     
     
         8 . The inhalation device of  claim 1 , wherein the nozzle comprises a plurality of pairs of ejection channels, wherein the exit openings of the ejection channels of one of the pairs, with respect to the main axis which forms a symmetry axis, are in rotated positions relative to the exit openings of the ejection channels of another one of the pairs, and wherein the respective cross channels are, along said symmetry axis, spaced apart from one another. 
     
     
         9 . The inhalation device of  claim 1 , wherein the nozzle is constructed as a stack of two-dimensional plate. 
     
     
         10 . The inhalation device of  claim 5 , wherein the reservoir is firmly attached to the pumping chamber and thus moveable inside the housing. 
     
     
         11 . (canceled) 
     
     
         12 . The inhalation device of  claim 1 , wherein the liquid composition comprising pirfenidone is an aqueous solution or suspension. 
     
     
         13 . A method for delivering pirfenidone to a subject in need thereof, the method comprising: providing an inhalation device according to  claim 1  to said subject. 
     
     
         14 . A method of treating a subject suffering from a lung disease or condition, the method comprising administering pirfenidone to said subject using the inhalation device according to  claim 1 . 
     
     
         15 . The inhalation device of  claim 1 , wherein the single dose of the liquid composition comprises an amount of at least 5.0 mg of pirfenidone. 
     
     
         16 . The inhalation device of  claim 8 , wherein the nozzle exhibits a front side and a back side opposite to the front side, wherein the front side comprises the exit openings of the ejection channels. 
     
     
         17 . The inhalation device of  claim 16 , wherein the back side is essentially flat and comprises a plurality of openings to form inlets to said main feed channel(s). 
     
     
         18 . The inhalation device of  claim 9 , wherein the nozzle is constructed from a three-dimensional rotation symmetric basic shape. 
     
     
         19 . The inhalation device of  claim 5 , wherein the reservoir is connected to the pumping chamber by a flexible element and firmly attached to the housing. 
     
     
         20 . The inhalation device of  claim 1 , wherein the liquid composition comprises one or more buffering agents, co-solvents, and combinations thereof. 
     
     
         21 . An inhalation device for the generation of an aerosol, the device comprising at least one reservoir containing a liquid composition comprising pirfenidone, wherein the inhalation device is a pump-actuated inhaler adapted to release upon actuation a metered dose of the liquid composition from the reservoir through a nozzle having at least three ejection channels adapted to eject the composition along respective ejection trajectories, and wherein at least one collision point is provided at which at least two of said ejection trajectories intersect with one another, wherein the single dose of the liquid composition comprises an amount of at least 4.0 mg of pirfenidone. 
     
     
         22 . The inhalation device of  claim 21 , wherein the single dose of the liquid composition comprising pirfenidone is released by a plurality of actuations of the inhalation device.